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Lot Number 7RSL021
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Pain (1994); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); Ambulation Difficulties (2544); No Code Available (3191)
Event Date 11/14/2017
Event Type  Injury  
Event Description
This unsolicited case from united states was received on (b)(6) 2018 from patient. This case concerns a (b)(6) year old female patient who received treatment with synvisc one and after few hours pain/pain wakes her up at night/a lot of pain in her left knee; after unknown latency patient pain wakes her up at night, bear weight to walk but it hurts, could hardly walk at all, hot all the time anyway. Also, device malfunction was identified for the reported lot number. No concomitant medications and concurrent conditions were reported. Patient previously received an injection in left knee 6 months ago but was unsure if it was synvisc or another gel product. Patient was weight bearing prior to injection. Patient denied pacemaker or icd but reports total knee replacement in right knee (unaffected knee). Patient denied taking immunosuppressants or being immunocompromised; mentioned having a "low immune system" but clarified she catches cold easily and has not been diagnosed with immune problems. Patient denied allergies to avian products or eggs, feathers. Patient denied diabetes, hypertension or any other significant health issues and mentioned being pretty healthy for age and weight. On (b)(6) 2017, patient received treatment with intra articular synvisc one injection at a dose of 6 ml once (lot number: 7rsl021 and expiration date: not reported) for osteoarthritis in the left knee. On the same day, after few hours of receiving injection, pain woke her up at night and she has swelling and a lot of pain in her left knee. Patient has a follow up appointment with hcp (health care professional) next thursday and anticipates they would draw labs and do other testing. Knee was not measured before or after injection. Pain rated as 10/10 initially and she needed to take vicodin but now it was generally 7/10 but was 10/10 when it woke her at night. On an unknown date in (b)(6) 2017, after unknown latency, it was reported that now patient could bear weight to walk but it hurts and for first 2 weeks "could hardly walk at all. " patient also has an "ice machine" that fits onto leg and she was using it "a whole lot" initially but now used it once daily. Pain began "almost immediately" the night after injection. On the same day in 2017, after unknown latency, patient denied fever but reported she was "hot all the time anyway" so could not be sure. Patient reported limping. Patient reported that is now taking ibuprofen bid. Corrective treatment: hydrocodone bitartrate/paracetamol (vicodin), ibuprofen, ice machine for pain/pain wakes her up at night/a lot of pain in her left knee; ice machine for could hardly walk at all and bear weight to walk but it hurts; not reported for rest events outcome: unknown for all the events. An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021. The product met all release testing at time of manufacture in june 2017. Retain samples were retested due to the unexpected increase in adverse events. Higher than expected endotoxin results were obtained. In addition, the presence of microbial contamination was also confirmed. The cause of these events is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Seriousness criteria: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 18-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced weight bearing difficulty, sleeping difficulty and difficulty walking. A temporal relationship can be established with the product administration. Furthermore, the concerned lot number has been identified to have malfunction by the company. Therefore, the causal relationship of the events to the products cannot be excluded.
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Type of DeviceMOZ
Manufacturer (Section D)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
bridgewater, NJ 08807
MDR Report Key7230637
MDR Text Key99190437
Report Number2246315-2018-00186
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 01/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/01/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/31/2018 Patient Sequence Number: 1